The INTERCLIMA (Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome) is a multi-center, prospective, randomized trial of optical coherence tomography (OCT)-based versus physiology-based (i.e. fractional flow reserve\[FFR\]/instantaneous Wave-Free Ratio\[iFR\]/resting full-cycle ratio\[RFR\]) treatment of intermediate (40-70% diameter stenosis), non-culprit coronary lesions in acute coronary syndrome (ACS) patients undergoing coronary angiography. About 1420 patients with ACS will be randomized into the study at approximately 40 sites worldwide.
Age of at least 18 years.
Diagnosis of acute coronary syndrome.
Single or multiple intermediate lesions in intervention-naïve major coronary segments (diameter ≥2.5 mm) determining a 40-70% diameter stenosis by visual assessment with no other significant stenosis (>70%) in the same vessel.
Patient informed of the nature of the study, agreeing to it, and providing written informed consent as approved by the Ethics Committee of the respective clinical study site.
Female with childbearing potential or lactating.
Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl).
Advanced heart failure (NYHA III-IV)
Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time.
Parallel
Optical coherence tomography
DeviceOCT images will be acquired by means of the FD C7 XR system or the OPTIS system (both St. Jude Medical, St. Paul, MN, USA) with a non-occlusive technique.(33) The acquired OCT coronary images will be analyzed on-line using a proprietary OCT console (St Jude Medical, Inc., USA). Definitions and cut-offs for OCT vulnerability parameters derived from available consensus documents and from main IVUS/OCT studies.
iFR/FFR/RFR
DeviceThe iFR and FFR measurements will be obtained using a coronary-pressure guidewire (Pressure Wire / Certus or Aeris for FFR assessment and PressureWire™ X Guidewire/QUANTIEM™ for the RFR assessment by Abbott Vascular, Abbott Park, Illinois, U.S.A; Comet by Boston Scientific, Marlborough, MA, USA), OptoWire by Opsens, Quebec, Canada, or Verrata by Philips, San Diego, CA, USA.).
Number of patients with cardiac death or non-fatal spontaneous target-vessel myocardial infarction
Composite outcome. Cardiac death will be defined as any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death. Any spontaneous myocardial infarction will be attributed to the randomized intermediate lesion if not clearly attributable to the non-target vessels.
Number of patients with cardiac death
Cardiac death will be defined as any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death.
Number of patients with non-fatal spontaneous target-vessel Myocardial infarction (excluding peri-procedural MI)
Any spontaneous myocardial infarction will be attributed to the randomized intermediate lesion if not clearly attributable to the non-target vessels.
Number of patients with target lesion revascularization (either percutaneous or surgical)
Repeated lesion revascularization will be considered in case of repeated percutaneous coronary intervention and coronary artery bypass grafting the enrolled lesions.
Number of patients with composite of cardiac death and any myocardial infarction
Composite outcome. Cardiac death will be defined as any death due to heart disease, including heart failure, myocardial infarction, arrhythmia, and sudden unexpected death. Any spontaneous myocardial infarction will be collected regardless of the culprit vessel involved.
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Centro per la Lotta Contro l'Infarto - Fondazione Onlus
Lead sponsor
Abbott Vascular (Santa Clara, USA)
Collaborator
